Study Objectives
Concise statements of the major and minor questions that the study is designed to answer. Objectives are often identified as primary or secondary. (Pfizer)
READ MOREStudy Design
The investigative methods used in the clinical study. For interventional studies, these include Primary Purpose, Intervention Model (Design), Masking (or Blinding), and Allocation. (See also Study Design data element on […]
READ MOREStudy Completion Date
The date that the final data for a clinical study were collected because the last study participant has made the final visit to the study location (i.e., “last subject, last […]
READ MOREStratified Randomization
Method of randomization that randomly assigns subjects to treatment groups according to the presence or degree of potential outcome modifiers such as age, severity of disease, or degree of overweight. […]
READ MOREStandard Operating Procedures (SOPs)
Detailed, written instructions to achieve uniformity of the performance of a specific function. (Pfizer)
READ MOREStandard of Care
1. A diagnostic and treatment process that a clinician should follow for a certain type of patient, illness, or clinical circumstance. 2. In legal terms, the level at which the […]
READ MORESponsor
An industry partner who provides funding to a University to conduct a research project. An individual, company, institution, or organization taking responsibility for initiation, management, and/or financing of a clinical […]
READ MORESource Documents
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or […]
READ MORESource Document Verification (SDV)
The process of validating the data that are collected on CRFs against source data. (Pfizer)
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